Senior Clinical Research Specialist
1 week geleden
Careers that Change Lives
Are you ready for this exciting role as a Clinical Research Specialist (CRS) where you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release?
This role involves leading study management duties and driving processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies.
As a Clinical Research Specialist, you will work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. You will assume project management responsibilities for selected studies and site management activities as needed.
This role utilizes your broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature.
The position provides work direction and strategic oversight of personnel supporting their trial. Maastricht with hybrid working possibilities and ability to travel (10-20%).
Peripheral Vascular Health Operating Unit
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization and Superficial and Deep Venous Disease.
We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
As a Clinical Research Specialist, you will lead a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
A Day in the Life
- Oversees, designs, plans, and develops clinical evaluation research studies for products that are under Clinical Investigation.
- Prepares and authors clinical study documents i.e protocols and patient record forms.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Oversees and interpret results of clinical investigations in preparation for new device or consumer application.
- Oversees and manages operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
- Serves as liaison between program management and planning, study team, and leadership
- Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats and others.
- Reviews status of projects and budgets; manages schedules and prepares status reports.
- May be responsible for clinical supply operations, site and vendor selection.
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